UMIN ID: C000000117
Registered date:06/09/2005
Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | elderly patients with advanced non-small cell lung cancer |
| Date of first enrollment | 2000/05/01 |
| Target sample size | 180 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | docetaxel 60 mg/m2 on day 1,repeated every 21 days over four cycles vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles. |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome | safety,efficacy,QOL |
Key inclusion & exclusion criteria
| Age minimum | 70years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or asites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded. |
Related Information
| Primary Sponsor | West Japan Oncology Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichiro Nakamura |
| Address | Japan |
| Telephone | 06-6633-7400 |
| datacenter@wjog.jp | |
| Affiliation | West Japan Oncology Group WJOG datacenter |
| scientific contact | |
| Name | Shinzoh Kudoh, MD |
| Address | 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan, 545-8585 Japan |
| Telephone | |
| Affiliation | Osaka City University Medical School Department of Respiratory Medicine |